Quality and Reliability

Radford, J. D.; Richardson, D. B.

doi:10.1007/978-1-349-15805-8_11

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The Role Of Inspections1

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2004

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“…Inspectors were organised into quality departments that were given the final responsibility for product quality. The head of the quality department reported directly to the highest level of management [4].…”

Section: The Role Of Inspectionsmentioning

confidence: 99%

Data quality of the clinical trial process – costly regulatory compliance at the expense of scientific proficiency

Lörstad

2004

Quality Assurance Journal

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The reasons for the belief in the need for perfection of clinical data are carefully nursed myths. The logical shortcomings in Good Clinical Practice are nothing but embarrassing to its scientifically trained promoters. Modern quality management methods, which increasingly degrade the importance of inspections, are described and their application in clinical research recommended. The documentation of procedures to attain acceptable quality levels of trial data is suggested to be standardized into a Quality Declaration. Copyright © 2004 John Wiley & Sons, Ltd.

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Section: The Role Of Inspectionsmentioning

confidence: 99%

Data quality of the clinical trial process – costly regulatory compliance at the expense of scientific proficiency

Lörstad

2004

Quality Assurance Journal

View full text Add to dashboard Cite

show abstract

Quality and Reliability

Cited by 1 publication

References 0 publications

Data quality of the clinical trial process – costly regulatory compliance at the expense of scientific proficiency

Data quality of the clinical trial process – costly regulatory compliance at the expense of scientific proficiency

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